RINVOQ (upadacitinib)
RINVOQ is indicated for the treatment of Moderately to severely active rheumatoid arthritis; Active psoriatic arthritis; Refractory, moderate to severe atopic dermatitis; Moderately to severely active ulcerative colitis; Moderately to severely active Crohn’s disease.
How RINVOQ Works
Upadacitinib is an intracellular enzyme inhibitor that targets the Janus kinase (JAK) family to influence immune cell function and hematopoiesis. It works by blocking JAKs from phosphorylating and activating signal transducers and activators of transcription (STATs), which are responsible for modulating gene expression. By preventing this activation, the drug modulates signaling pathways arising from cytokine or growth factor-receptor interactions on the cellular membrane. In laboratory assays, the drug demonstrates greater inhibitory potency at JAK1 and JAK2 relative to JAK3 and TYK2.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-08-16
- Patent Cliff
- 2038
- Revenue
- $2.1B (Q1-2026)
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
RINVOQ Approval History
What RINVOQ Treats
5 indicationsRINVOQ is approved for 5 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Moderately to severely active rheumatoid arthritis
- Active psoriatic arthritis
- Refractory, moderate to severe atopic dermatitis
- Moderately to severely active ulcerative colitis
- Moderately to severely active Crohn’s disease
RINVOQ Boxed Warning
SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with RINVOQ /RINVOQ LQ are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 )]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt RINVOQ /R...
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with RINVOQ /RINVOQ LQ are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 )]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt RINVOQ /RINVOQ LQ until the infection is controlled. Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before RINVOQ /RINVOQ LQ use and during therapy. Treatment for latent infection should be considered prior to RINVOQ /RINVOQ LQ use. Invasive fungal infections, including cryptococcosis and pneumocystosis. Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens. The risks and benefits of treatment with RINVOQ /RINVOQ LQ should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with RINVOQ /RINVOQ LQ , including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy [see Warnings and Precautions ( 5.1 )]. MORTALITY In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor [see Warnings and Precautions ( 5.2 )] . MALIGNANCIES Lymphoma and other malignancies have been observed in patients t
RINVOQ Target & Pathway
ProTarget
A member of the JAK family involved in signaling for interferons and several interleukins. JAK1 inhibition is effective in rheumatoid arthritis, atopic dermatitis, and other inflammatory conditions by blocking multiple cytokine pathways.
RINVOQ Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in RINVOQ's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications RINVOQ treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to RINVOQ
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
66 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06332534 U-EMPOWER | M14-671 2023-509618-12 | Ph 3 | recruiting | Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease |
| NCT06012240 Up-AA | M23-716 2023-505061-82-01 | Ph 3 | recruiting | A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata |
| NCT05843643 SELECT-SLE | M23-699 2023-503655-10-00 | Ph 3 | active not recruiting | Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus |
| NCT07550673 | KY20252556-F-1-2 | Ph 4 | recruiting | Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE） |
| NCT07510191 CD | 2026ZSLYEC-158 | Ph 4 | recruiting | TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response |
| NCT07546097 | KY20252556-F-1-1 | Ph 4 | recruiting | Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis（UPFRONT） |
| NCT07425899 | M25-431 | Ph 1 | recruiting | A Phase 1 Study of the Safety and How the Body Processes ABBV-722 and Upadacitinib After Multiple Oral Doses in Healthy Adult Participants |
| NCT07502339 | 26-46306 | Ph 4 | not yet recruiting | Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis |
| NCT03345823 U-ENDURE | M14-430 2023-504951-29, 2023-504951-29-00 | Ph 3 | active not recruiting | A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433 |
| NCT06461897 Start Up | M17-380 2023-504713-76-00 | Ph 3 | recruiting | A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis |
| NCT06928272 | LC-Revitalize | Ph 3 | recruiting | Long Covid (LC)-REVITALIZE - A Long Covid Repurposed Drug Study |
| NCT07492251 Upa_LP | 25-PP-10 | Ph 2 | not yet recruiting | Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Randomized Placebo-controlled Study. |
| NCT05889182 Step-Up HS | M23-698 2023-503661-28-00 | Ph 3 | recruiting | A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy |
| NCT04169373 SELECT-AXIS 2 results posted | M19-944 2022-501018-78-00 | Ph 3 | completed | A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis |
| NCT03725202 SELECT-GCA results posted | M16-852 2023-505476-29-00, 2017-003978-13 | Ph 3 | completed | A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis |
| NCT06701331 Start Up Japan | M25-145 | Ph 3 | active not recruiting | Safety and Efficacy of Upadacitinib in Combination With Topical Corticosteroids in Children From 2 to Less Than 12 Years of Age in Japan With Moderate to Severe Atopic Dermatitis |
| NCT04161898 SELECT-TAK | M19-052 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK) |
| NCT05609630 SELECT-sJIA | M14-682 2022-501599-25-00 | Ph 3 | recruiting | Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis. |
| NCT07352566 | 25-43621 | Ph 4 | not yet recruiting | Utilization of a Microdevice for Psoriasis and Atopic Dermatitis |
| NCT05814627 SELECT- SWITCH | M23-700 2022-502578-18-00 | Ph 3 | active not recruiting | Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis |
| NCT05782907 U-ASTOUND | M14-658 2022-501788-41-00 | Ph 3 | active not recruiting | Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis. |
| NCT07023302 Jump Up AA JP | M24-600 | Ph 3 | recruiting | A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants in Japan With Alopecia Areata |
| NCT03568318 AD Up results posted | M16-047 2017-005126-37 | Ph 3 | active not recruiting | A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis |
| NCT03607422 results posted | M18-891 2022-502936-38-00 | Ph 3 | completed | A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2) |
| NCT06118411 Viti-Up | M19-044 2023-506195-27-00 | Ph 3 | active not recruiting | A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo |
| NCT03569293 Measure Up 1 results posted | M16-045 2022-502938-30-00 | Ph 3 | completed | Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema) |
| NCT03104400 SELECT - PsA 1 results posted | M15-572 2016-004130-24 | Ph 3 | completed | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) |
| NCT03104374 SELECT - PsA 2 results posted | M15-554 2016-004152-30 | Ph 3 | completed | A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug |
| NCT07149467 | 2024ZSLYEC-312 | Ph 3 | not yet recruiting | Ustekinumab and Upadacitinib for Induction and Maintenance Therapy in Patients With Refractory Crohn's Disease: A Multicenter, Randomized, Parallel-Controlled Study |
| NCT07138898 | 25-00380 | Ph 2 | not yet recruiting | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty |
| NCT03725007 SELECT-YOUTH | M15-340 2018-000715-25 | Ph 1 | active not recruiting | A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis |
| NCT02629159 SELECT-COMPARE results posted | M14-465 2022-501017-31-00 | Ph 3 | active not recruiting | A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate |
| NCT05507580 Flex-Up results posted | M22-000 2022-000434-42 | Ph 4 | completed | A Study to Assess Treat-to-Target and Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis |
| NCT07064889 | ITP-UPA-001 | Ph 2 | not yet recruiting | The Combination of Upadacitinib and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia |
| NCT06227910 VICTRIVA | Vedolizumab-3043 2023-509391-42-00 | Ph 3 | recruiting | A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease |
| NCT05080218 COVER | COVER-Main | Ph 4 | completed | COVID-19 VaccinE Response in Rheumatology Patients |
| NCT06902987 | 2024ZSLYEC-371 | Ph 1 | recruiting | Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease |
| NCT06873100 | Upadacitinib RP | Ph 1, Ph 2 | recruiting | Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis |
| NCT05601882 Level Up results posted | M23-696 2022-002482-15 | Ph 3 | completed | A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis |
| NCT06773403 | ETC03 | Ph 4 | terminated | Upadacitinib for Prurigo Nodularis |
| NCT04451772 results posted | M20-186 2020-001690-72 | Ph 2 | completed | A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State |
| NCT04195698 results posted | M19-850 2019-001227-12 | Ph 3 | completed | Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis |
| NCT04927975 results posted | M19-051 2021-000081-15 | Ph 2 | completed | Study to Evaluate Adverse Events and Change in Disease Activity With Oral Tablets of Upadacitinib in Adult Participants With Non-Segmental Vitiligo |
| NCT06390722 Sleep Up | M24-602 | Ph 3 | withdrawn | A Study to Assess the Effect of Upadacitinib in Atopic Dermatitis-induced Sleep Disturbance in Adults With Moderate to Severe Atopic Dermatitis |
| NCT03086343 results posted | M15-925 2016-000933-37 | Ph 3 | completed | A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs |
| NCT03738397 Heads Up results posted | M16-046 2018-002264-57 | Ph 3 | completed | A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis |
| NCT02706951 results posted | M15-555 2015-003376-75 | Ph 3 | completed | A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY) |
| NCT03978520 SLEek results posted | M19-130 2019-000638-20 | Ph 2 | completed | A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE) |
| NCT02706873 SELECT-EARLY results posted | M13-545 2015-003334-27 | Ph 3 | completed | A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate |
| NCT02720523 SELECTSUNRISE results posted | M14-663 | Ph 2, Ph 3 | completed | A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis (RA) Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs |
Showing 50 of 66 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RINVOQ FDA Label Details
Indications & Usage
FDA Label (PDF)RINVOQ is indicated for the treatment of Moderately to severely active rheumatoid arthritis; Active psoriatic arthritis; Refractory, moderate to severe atopic dermatitis; Moderately to severely active ulcerative colitis; Moderately to severely active Crohn’s disease.
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with RINVOQ /RINVOQ LQ are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ), ...
RINVOQ Patents & Exclusivity
Patents (45 active)
Exclusivity
Pro Intelligence Preview
Deep insights for RINVOQ
Revenue Insights
- • Q1-2026: $2.1B
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 291 active patents
Trial Analysis
- • 66 total trials
- • Stage: Expansion
Competitive Landscape
- • 5 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Related Intelligence
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment